MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER W/ SHERLOCK 3CG (TPS) STYLET FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Extravasation (1842); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported line fracture and leaking during administration of oxaliplatin at 12cm caused line to be removed.Picc was 15 days in situ.Trim length 50 cm, 8 cm external, 42 cm internal.Inserted in right basilic vein.Patient reported that picc was leaking during administration of oxaliplatin.The leak occurred inside the skin of the patient with infiltration/extravasation of the fluid in the patient¿s tissue and coming out through the exit site of the picc.Patient experienced, swelling, oedema and pain.(25 % oxaliplatin infusion had been administered when event happened).Extravasation of oxaliplatin occurred.Picc was removed and fracture of the line was seen at 12 cm mark of the catheter.Patient had to go through extravasation pathway.Swelling, pain, oedema an tissue injury occurred.Patient could not complete her chemotherapy cycle which was delayed.Patient will need a new picc inserted to resume their anticancer treatment.No other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2024-06124 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2024-06148.
Event or Problem Description
It was reported line fracture and leaking during administration of oxaliplatin at 12 cm caused line to be removed.Picc was 15 days in situ.Trim length 50 cm, 8 cm external, 42 cm internal.Inserted in right basilic vein.Patient reported that picc was leaking during administration of oxaliplatin.The leak occurred inside the skin of the patient with infiltration/extravasation of the fluid in the patient¿s tissue and coming out through the exit site of the picc.Patient experienced, swelling, oedema and pain.(25 % oxaliplatin infusion had been administered when event happened).Extravasation of oxaliplatin occurred.Picc was removed and fracture of the line was seen at 12 cm mark of the catheter.Patient had to go through extravasation pathway.Swelling, pain, oedema an tissue injury occurred.Patient could not complete her chemotherapy cycle which was delayed.Patient will need a new picc inserted to resume their anticancer treatment.No other information was provided.

• Brand Name: POWERPICC SOLO2 CATHETER W/ SHERLOCK 3CG (TPS) STYLET FULL TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20509866
• Report Number: 3006260740-2024-06124
• Device Sequence Number: 7969305
• Product Code: LJS
• UDI-Device Identifier: 00801741140952
• UDI-Public: (01)00801741140952(11)240430(17)250831(10)REJQ1584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000375
• Device Lot Number: REJQ1584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown